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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208768

300MG/16.7ML (18MG/ML)
Marketing Status: Prescription
Active Ingredient: POSACONAZOLE
Proprietary Name: POSACONAZOLE
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 300MG/16.7ML (18MG/ML)
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A208768
Product Number: 001
Approval Date: May 25, 2022
Applicant Holder Full Name: PAR STERILE PRODUCTS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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